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GD-11 for Injection in the Treatment of Acute Ischemic Stroke

NCT06299579 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2024-03-15

No results posted yet for this study

Summary

Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

GD-11 for injection test group

The first dose of GD-11 was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

DRUG

Placebo control group

The first dose of placebo was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

Sponsors & Collaborators

  • Jiangsu Wangao Pharmaceutical Co. ltd

    collaborator UNKNOWN

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Shuya Li · IRB of Beijing Tiantan Hospital Capital Medical University Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-02-22
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299579 on ClinicalTrials.gov